Method of administration: For oral use.
Dosage regimen: Tablet-taking can be started on any day of the menstrual cycle.
The dosage of Dienogest (Vinca) is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.
Management of missed tablets: The efficacy of Dienogest (Vinca) may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occurring within 3-4 hours after tablet taking). In the event of missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet.
Additional information on special populations: Paediatric population: Dienogest (Vinca) is not indicated in children prior to menarche.
The efficacy of Dienogest (Vinca) in adolescents over a treatment period of 12 month was associated with a mean decrease in Bone Mineral Density (BMD) in the lumbar spine of 1.2%. After cessation of treatment, BMD increased again in these patients.
Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life. Therefore, the treating physician should weigh the benefits of Dienogest (Vinca) against the possible risks of use in each individual adolescent patient (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Geriatric Population: There is no relevant indication for use of Dienogest (Vinca) in the geriatric population.
Patients with hepatic impairment: Dienogest (Vinca) is contraindicated in patients with present or past severe hepatic disease (see Contraindications). Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.
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